Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-03-05 @ 12:30 AM
Study NCT ID:
NCT03140358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-18
First Post:
2017-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spherical Equivalent', 'timeFrame': '3.5 years', 'description': 'SE'}], 'secondaryOutcomes': [{'measure': 'Axial Length', 'timeFrame': '3.5 years', 'description': 'AL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.', 'detailedDescription': 'High risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n1. One parent with myopia (\\<-3D in at least one eye)\n2. SE +1.00D to -1.50D\n3. Astigmatism \\< = 1.50D\n4. Distance vision logMAR 0.2 or better in both eyes\n5. Intraocular pressure of not greater than 21 mmHg\n6. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride\n\nExclusion Criteria:\n\n1. Any eye or systemic disease that affect vision or refractive error\n2. Conditions where topical atropine contraindicated\n3. Previous use of atropine or pirenzepine\n4. Known past/current amblyopia or strabismus'}, 'identificationModule': {'nctId': 'NCT03140358', 'briefTitle': 'The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Singapore National Eye Centre'}, 'officialTitle': 'The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)', 'orgStudyIdInfo': {'id': 'R1359/45/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Premyopia atropine', 'description': 'On Atropine 0.01%', 'interventionNames': ['Drug: Atropine sulfate 0.01%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Premyopia placebo', 'description': 'On placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low myopia atropine', 'description': 'On Atropine 0.01% daily or every other day', 'interventionNames': ['Drug: Atropine sulfate 0.01%']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Low myopia placebo', 'description': 'On placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atropine sulfate 0.01%', 'type': 'DRUG', 'description': 'Atropine 0.01%', 'armGroupLabels': ['Low myopia atropine', 'Premyopia atropine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['Low myopia placebo', 'Premyopia placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '423699', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore eye research institute', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Audrey Chia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Singapore National Eye Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Singapore National Eye Centre', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Medical Research Council (NMRC), Singapore', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjuct Associate Professor', 'investigatorFullName': 'Audrey Chia Wei-Lin', 'investigatorAffiliation': 'Singapore National Eye Centre'}}}}